The Daily Biotech Pulse: Sanofi Reports Positive Readout, Tonix Vaccine Candidate Aces Animal Study, Hologix's Weak Guidance

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week highs on Jan. 29)

• 10X Genomics Inc TXG
• Agile Therapeutics Inc AGRX
• Aptose Biosciences Inc APTO
• Catalent Inc CTLT
• Cabaletta Bio Inc CABA(announced grant of orphan drug designation for its DSG3-CAART for the treatment of pemphigus vulgaris)
• AtriCure Inc. ATRC
• Dr.Reddy's Laboratories Ltd RDY
• Fate Therapeutics Inc FATE
• Hologic, Inc. HOLX
• Insulet Corporation PODD
• Johnson & Johnson JNJ(confirmed it is working on treatment/vaccines for coronavirus)
• Nevro Corp NVRO
• Profound Medical Corp PROF
• Quest Diagnostics Inc DGX
• ResMed Inc. RMD
• Satsuma Pharmaceuticals Inc STSA(reacted to publication of positive data readout for its lead drug candidate)
• Tandem Diabetes Care Inc TNDM
• West Pharmaceutical Services Inc. WST
• Zimmer Biomet Holdings Inc ZBH

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 29)

• Avanos Medical Inc AVNS
• Enanta Pharmaceuticals Inc ENTA
• Endologix, Inc. ELGX
• Galectin Therapeutics Inc. Common Stock GALT
• MediciNova, Inc. MNOV
• X4 Pharmaceuticals Inc XFOR
• VIVUS, Inc. VVUS

Stocks In Focus

Sanofi Reports Positive Results For Its Lipid Storage Disorder Drug

Sanofi SA SNY said Olipudase alfa, an investigational recombinant human acid sphingomyelinase, showed positive results in two separate Phase 2/3 clinical trials evaluating it for the treatment of acid sphingomyelinase deficiency in adult and pediatric populations. The data will form the basis of global regulatory submissions, expected to begin in the second half of 2021, the company said.

Astellas, FibroGen Seek Label Expansion For Anemia Drug In Japan

FibroGen Inc FGEN and ASTELLAS PHARMA/ADR ALPMY announced the submission of a sNDA to Japan's Ministry of Health, Labour and Welfare's to get marketing approval for roxadustat for the treatment of anemia associated with chronic kidney disease in non-dialysis dependent patients.

Roxadustat has already been approved in Japan for the treatment of anemia associated with CKD in dialysis dependent patients.

Tonix' Small Pox Vaccine Candidate Found Effective In Animal Study

Tonix Pharmaceuticals Holding Corp TNXP presented at the 2020 ASM Biothreats Conference, held in Arlington, Virginia, preclinical data for its TNX-801, a live virus vaccine for precutaneous administration, which showed that all eight animals vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox.

In contrast, two of the three evaluable patients vaccinated with TNX-1200 and all animals who received vehicle control developed monkeypox lesions after challenge.

Tonix is developing TNX-801 and TNX-1200 as potential smallpox preventing vaccines for the U.S. strategic national stockpile and as monkeypox preventing vaccines for areas where monkeypox is a growing problem.

The stock gained 4.38% to $1.43 53 in after-hours trading.

Hologic Q1 EPS In Line; Issues Lackluster Guidance

Hologic's 2020 first-quarter revenues rose 2.4% to $850.5 million and non-GAAP EPS rose 5.2% to 61 cents, in line with the Street estimate. The company lowered its full year revenue guidance and tightened its non-GAAP EPS guidance, while its second-quarter guidance trailed the consensus estimate.

The stock slipped 3.02% to $53 in after-hours trading.

Illumina Q4 EPS Beat Estimate

Illumina, Inc.'s ILMN fourth-quarter revenues climbed 10% to $953 million and non-GAAP EPS increased from $1.32 to $1.70, exceeding the consensus estimate of $1.58. For 2020, the company expects revenue growth of 9-11% and non-GAAP EPS of $6.80-$7. Analysts, on average, estimate 11% revenue growth and EPS of $6.91.

The stock retreated 4.92% to $297.90 in after-hours trading.

Offerings

Catabasis Pharmaceuticals Inc CATB said it intends to offer shares in an underwritten public offering. The company said it intends to use the net proceeds for clinical trials and other R&D activities, initial commercialization preparations, and for working capital and other corporate purposes.

The stock slipped 8.29% to $5.20 in after-hours trading.

Selecta Biosciences Inc SELB filed with the SEC a prospectus regarding the sale of securities amounting to 68.97 million by selling shareholders. Of this 37.63 million shares are presently issued and outstanding and 31.33 million shares are issuable upon exercise of warrants to purchase common shares. The company said it will not receive any proceeds from the offering.

The stock fell 7.09% to $2.75 in after-hours trading.

DBV TECHNOLOGIE/S ADR DBVT said it has priced a global offering of 7.5 million ordinary shares, comprising a public offering of 4.54 million ordinary shares in the form of ADSs in the U.S., Canada and certain countries outside of Europe, at $10.25 per ADS, and an offering exclusively for qualified investors in Europe numbering 2.96 million ordinary shares at a public offering price of 18.63 euros per ordinary share.

The stock moved down 5.12% to $10.75 in after-hours trading.

Applied Genetic Technologies Corp AGTC has filed with the SEC for a common stock offering.

The stock declined 4.89% to $7 in after-hours trading.

Albireo Pharma Inc( ALBO said it has commenced a proposed underwritten public offering of its common stock. All shares are to be sold by the company.

The stock fell 4.91% to $22.66 in after-hours trading.

Earnings

Quest Diagnostics Inc DGX (before the market open)
Alexion Pharmaceuticals, Inc. ALXN (before the market open)
Eli Lilly And Co LLY (before the market open)
Biogen Inc BIIB (before the market open)
Amgen, Inc. AMGN (after the market close)
Edwards Lifesciences Corp EW (after the market close)
ResMed (after the market close)
Vertex Pharmaceuticals Incorporated VRTX (after the market close)

IPO

Black Diamond Therapeutics priced its upsized offering of 10.59 million shares at $19, higher than the estimated price range of $16-$18. The company expects to list the shares on the Nasdaq under the ticker symbol "BDTX."